Dose Ranging Study of Ba 679 BR Inhalation Powder in Chronic Obstructive Pulmonary Disease (COPD) Patients

Dose Ranging Study of Ba 679 BR Inhalation Powder Following Single Inhalation in COPD Patients - Double-blind, Placebo-controlled, 4 Treatment, 4 Period Crossover Study-

To investigate the dose response following single inhalation of Ba 679 BR inhalation powder in COPD patients using pulmonary functions as indicators, and to compare data obtained with overseas study findings

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Ba 679 BR low dose; Drug: Placebo inhalation powder; Drug: Ba 679 BR middle dose; Drug: Ba 679 BR high dose

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. In a pulmonary function test of Screening Test II, FEV1.0 was less than 70% of predict normal and FEV1.0 was less than 70% of FVC.
2. In the reversibility test of Screening Test II, FEV1.0 was improved by 10% or more at 1 hour after inhalation of 2 puffs of an anticholinergic agent (Tersigan ® Aerozol)
3. History of smoking (< no. of cigarettes a day x no. of years of smoking > = 200 or more)
4. 40 years of age or older
5. Regardless of sex and the length of disease period

Exclusion Criteria:

1. A history of bronchial asthma
2. A history of atopic disease, such as allergic rhinitis
3. Blood eosinophil of 440/µl or more
4. Continuous use of steroid drugs (oral administration, inhalation or injection) at a dose equivalent to over 5 mg daily of prednisolone
5. A history of respiratory infection, including virus infection within 1 month before study initiation
6. Tuberculosis, lung cancer or a history of pneumonectomy
7. Glaucoma
8. Under treatment of benign prostatic hypertrophy
9. Hypersensitivity to anticholinergic agents or sympathomimetics
10. Difficulty in expectoration of sputum
11. Serious heart disease, renal disease, hepatic disease, endocrine disease or metabolic disease
12. Use of any β blockers
13. A history of myocardial infarction within the past 1 year
14. A history of heart failure, cor pulmonale or arrhythmia requiring medication within the past 3 years
15. A history of drug abuse or alcoholism
16. Treatment of psychotic disease
17. Pregnancy, possible pregnancy or lactation
18. A history of participation in any other clinical studies within the past 6 months
19. Judgment by the investigator that the patient is ineligible for inclusion in the present study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ba 679 BR low dose	Drug: Ba 679 BR low dose
Placebo Comparator: Placebo inhalation powder	Drug: Placebo inhalation powder
Experimental: Ba 679 BR middle dose	Drug: Ba 679 BR middle dose
Experimental: Ba 679 BR high dose	Drug: Ba 679 BR high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
FEV1.0 max (maximum forced expiratory volume in one second)	before and up to 24 hours after each study drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
FEV1.0 AUC 0-24 (forced expiratory volume in one second as area under the curve 0 to 24 hours after administration)	before and up to 24 hours after each study drug administration
FEV1.0 time to response	before and up to 24 hours after each study drug administration
FEV1.0 Tmax (time to FEV1.0 max)	before and up to 24 hours after each study drug administration
FEV1.0 at measuring time points up to 24 hours after administration of study drug	before and up to 24 hours after each study drug administration
FVC AUC 0-24 (forced vital capacity as area under the curve 0 to 24 hours after administration)	before and up to 24 hours after each study drug administration
FVC max	before and up to 24 hours after each study drug administration
FVC at measuring time points up to 24 hours after administration of study drug	before and up to 24 hours after each study drug administration
Occurrence of adverse events	up to 29 days
Changes in blood pressure	before and up to 24 hours after each study drug administration
Changes in pulse rate	before and up to 24 hours after each study drug administration
Changes in transdermal O2 saturation	before and up to 24 hours after each study drug administration
Abnormal findings in electrocardiogram (ECG)	before and 1.5 and 24 hours after each administration of study drug
Abnormal changes in laboratory measurements	at 24 hours after last study drug administration
Urinary excretion rate	before (from 4 hours pre-dosing until immediately before dosing) and 0-2, 2-4, 4-8, 8-12 and 12-24 hours after drug administration
MMEF AUC 0-24 (maximal midexpiratory flow as area under the curve 0 to 24 hours after administration)	before and up to 24 hours after each study drug administration
MMEF max	before and up to 24 hours after each study drug administration
MMEF at measuring time points up to 24 hours after administration of study drug	before and up to 24 hours after each study drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 1998
• Primary Completion (Actual): May 1, 1999

Study Registration Dates

• First Submitted: June 20, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Estimate): June 24, 2014
• Last Update Submitted That Met QC Criteria: June 20, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide
• Other Study ID Numbers: 205.139